Eppin Pharma Wants to Change the Way You Think About Birth Control


By Samantha Schisler, NC Biz News

In 2014, Dr. Michael O’Rand retired from UNC-Chapel Hill, leading him to start Eppin Pharma Inc., a company that could one day potentially disrupt the pharmaceutical industry.

O’Rand began his scientific career in the ‘70s focusing on marine biology, specifically the fertilization of marine life. This led him to become a reproductive biologist with more than 35 years of experience in studying mechanisms underlying human fertilization.

O’Rand also established the in vitro fertilization laboratory in UNC School of Medicine’s North Carolina Memorial Hospital and the first “test tube” baby in North Carolina.

O’Rand’s journey to founding Eppin Pharma began by trying to find an alternative to the female hormonal contraceptive.

“For a couple of years, we tried to find a way to create an alternative contraceptive to the female hormonal contraceptive,” said O’Rand. “While that worked out well for animals, such as elephants, seals and deer, it doesn’t really work for humans.”

From there, O’Rand and his team turned their attention to creating a non-hormonal male contraceptive pill.

In 2004, EPPIN, a secreted male-specific protein found on the surface of human sperm, was validated as a contraceptive target by immunizing male monkeys with EPPIN and showing it reversibly affected fertility.

“We knew what we needed to do was find a substitute for the antibody that inhibits the sperm,” said O’Rand. “That is when we started looking for small organic molecules.”

From there, a search for small organic molecules that could affect EPPIN function started.

In 2010, O’Rand and his team created a 3-D model of EPPIN and developed various analyses that allowed them to study EPPIN-SEMG1 interactions in-silico and in-vitro. This led them to zero in on a class of lead compounds that could be potential contraceptive drugs.

Soon afterward O’Rand received a grant from the National Institutes of Health and in 2014 founded Eppin Pharma in Chapel Hill, North Carolina.

The company is focused on developing a safe, effective short-term, non-hormonal oral male contraceptive pill with a vision to provide a new male contraceptive that will revolutionize family planning.

The Drug: How it works

Eppin Pharma’s lead male contraceptive candidate is a small compound that binds to EPPIN resulting in the loss of sperm motility.

“Our compound, which is called EPO55, binds to the sperm and as a result, it changes the sperm’s internal makeup,” said O’Rand. “It lowers the pH inside the sperm and basically affects the sperm membrane to where the sperm can’t swim forward anymore.”

EPO55 affects the sperm’s function by interfering with important membrane channels including ones for maintaining proper pH and calcium levels.

EPPIN is an androgen-dependent protein only found in males that is secreted in the testis and epididymis, it coats the surface of sperm throughout the male reproductive tract.

The SEMG-Eppin binding is critical for sperm to acquire motility and the ability to fertilize an egg. By interfering with this interaction, the company’s drug will keep sperm from becoming motile thereby acting as a contraceptive.

Once the drug is introduced into the body it will be distributed to various body fluids and tissues.

Non-hormonal options are preferable to a male hormonal contraceptive because they have no effect on sperm production or other male hormone-dependent functions.

“The good thing about our drug is that it has no effect on the making of sperm,” said O’Rand. “It is going to do the work in the epididymis and stop the sperm from swimming.”

Research and Bringing to Market

In April 2018, O’Rand and his team published the results of their successful proof-of-concept study in primates in PLOS ONE. The results can be found here.

The research found that 30 hours after receiving a high-dose of EP055 intravenously, the animals showed no indications of normal sperm motility.

Eighteen days after the treatment, all of the monkeys completely recovered their sperm motility, suggesting that EP055 is reversible. No side effects were apparent throughout the study.

“By injecting the compound intravenously, we found that sure enough the sperm in the ejaculate was affected and had no forward progress,” said O’Rand. “That’s where we are now and we are going to proceed from there by making an oral formulation.”

Next steps for Eppin Pharma include making an oral formulation of the drug and testing it on first animal subjects then, hopefully, human subjects through conducting a phase one clinical trial.

In order to do this, Eppin Pharma must get permission from the Food and Drug Administration, along with many more trials after the initial one.

“Once that clinical trial starts then you have to go through several more clinical trials before you can go to market, which could take a long time,” said O’Rand.

The phase one clinical trial would be the first time the drug would be tested on human subjects in order to ensure the safety of the drug. This helps the FDA and Eppin Pharma find if it is safe to administer the drug and to determine the proper dosage.

Currently, there are a number of different companies trying different things to bring a male contraceptive to market whether it is hormonal or non-hormonal. For example, Clean Sheets is working to develop a non-hormonal pill that works by blocking the release of semen when a man has an orgasm.

In the past five years, Eppin Pharma has received many grants and loans that have helped the company achieve the research needed to prove the efficacy of its drug. This includes a startup grant from UNC-CH’s KickStart Award Program and a small business research loan from the Biotech Center.

The Future for Eppin

In June 2018, the company moved its office and laboratory from Chapel Hill, North Carolina, to BioLabs North Carolina which is a biotech coworking facility in downtown Durham.

Here the company is continuing the process of developing an oral formulation of the drug, as well as, continuing experiments to make clear the mechanism of action of the drug.

“For right now we are just concentrating on this,” said O’Rand. “Our main focus is to bring our drug to a clinical trial.”

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